Why is this study being done?
This study will look at possible COVID-19 exposure and related symptoms. We would like to see if it is possible to tell who has COVID-19 with a survey, without going to a doctor’s office.
What will happen if I participate?
To be in this study, you will need to sign-up on the COVID-CARE website. You will be asked to complete surveys about yourself and complete 3 COVID-19 tests, provided to you at no cost. We expect that the study will take about 4 total hours of your time (spread across 7 days).
What will happen if I participate in the study?
We will ask you to answer questions about yourself, where you live, your health history, symptoms you may be experiencing right now, and any known exposures to COVID-19 or the Flu in the last 14 days. You may also be asked to answer questions about your experience in this study. We will send you an email or text notifications such as reminders to complete surveys.
As part of this study, you will be given two (2) at-home COVID-19 tests. You will take these tests on your own, without the help of anyone else. To take the test you will gently insert a medical swab (like a Q-Tip) into your nose. You will be given instructions on how to do this. After you complete your COVID tests you will be asked to enter the results into your COVID-CARE participant account.
After you have completed all study related procedures, we would like to ask you questions about how you liked being in the study, and if you have any suggestions for improving our study in the future.
You may also be asked to come to VCU’s drive-thru COVID-19 testing site. During this visit a VCU staff member will gently insert a medical swab (like a Q-tip) into your nose. Study staff will schedule this appointment with you. The results of this test will be available in your regular VCU Health medical record. Study staff members will view your medical record to see the results of this test only. There is no cost to you for this test.
What alternative treatments are available?
You do not have to be in this study in order to receive a COVID-19 test. Talk to the study staff or your regular doctor to see if this would be a good option for you.
What are the benefits of being in the study?
This is not a treatment study, and you are not expected to receive any direct medical benefits from your participation in the study. The information from this research study may lead to better testing options in the future for people with COVID-19.
What are the risks of being in the study?
1. COVID-19 Test Risks
You will probably feel some discomfort or pain from the COVID-19 nasal swab. If you are ever in any pain, you can stop the test at any time. There are no serious risks to receiving these tests.
2. Non-Physical Risks
Participation in research might involve some loss of privacy. There is a small risk that someone outside the research study could see and misuse information about you. Questionnaires may contain questions that are personal in nature. You may refuse to answer any question that makes you feel uncomfortable.
3. Unknown or Unforeseeable Risks
The study team will let you know about any significant new findings (such as additional risks or discomforts) that might make you change your mind about being in the study.
What are the costs?
COVID tests will be given to you by the study at no cost to you. You will not be charged for any study visits, tests, or procedures.
Will I be paid to participate in the study?
You will be paid by cash or by mailed check (your choice) for completing all study procedures.
What if I am injured or become sick?
If you are injured by, or become ill, from participating in this study, please contact your study doctor immediately. Medical treatment is available at the Virginia Commonwealth University Health System (VCU Health System). Your study doctor will arrange for short-term emergency care at the VCU Health System or for a referral if it is needed.
Fees for such treatment may be billed to you or to appropriate third-party insurance. Your health insurance company may or may not pay for treatment of injuries or illness as a result of your participation in this study. To help avoid research-related injury or illness, it is very important to follow all study directions.
Can I stop being in the study?
You can stop being in this research study at any time. Leaving the study will not affect your medical care, employment status, or academic standing at VCU or VCU Health. Tell the study staff if you are thinking about stopping or decide to stop.
Your participation in this study may be stopped at any time by the study doctor without your consent. The reasons might include:
- The study doctor thinks it is necessary for your health or safety
- You have not followed study instructions
- Administrative reasons require your withdrawal
How will my information be protected?
VCU and the VCU Health System have established secure research databases and computer systems to store information and to help with monitoring and oversight of research. Your information may be kept in these databases according to VCU’s policies (i.e. for a minimum of 5-6 years). It can only been seen by people working on this study or authorized individuals who have access for specific research related tasks.
Identifiable information in these databases are not released outside VCU unless stated in this consent or required by law. Although results of this research may be presented at meetings or in publications, identifiable personal information about participants will not be disclosed.
How will my health information be used?
As part of this research study, we will ask you to share identifiable health information with us and/or permit us to access existing information from your healthcare records. New health information may also be created from study-related tests, procedures, visits, and/or questionnaires and added to your healthcare records. This type of information is considered “Protected Health Information” that is protected by federal law.
What types of health information will be used?
The following types of information may be used for the conduct of this research:
- Diagnosis & treatment codes
- Laboratory test results
Who will see my information?
VCU and VCU Health are required by law to protect your identifiable health information. By consenting to this study, you authorize VCU/VCU Health to use and/or share your health information for this research. The health information listed above may be used by and/or shared with the following people and groups to conduct, monitor, and oversee the research:
- Principal Investigator and Research Staff
- Study Sponsor
- Health Care Providers at VCU Health
- Data Coordinators
- Institutional Review Boards
- Research Collaborators
- Government/Health Agencies
- Others as Required by Law
Once your health information has been disclosed to anyone outside of this study, the information may no longer be protected under this authorization.